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April 27, 2021

Amazon Dietary Supplements Policy: April 2021 Update

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Back in February 2021, Vorys eControl published an article on Amazon’s Dietary Supplements Policy. Since then, Amazon has made some changes to the Policy. In this article, we will discuss some of the noteworthy updates.

Amazon has perhaps clarified the applicability of the Policy.

In talking with brands, there was some confusion about what products were covered by the Policy. The updated Policy provides a bright-line test for whether a product is covered: “If your product has a Supplement Facts panel, you will be required to submit compliance documentation. If your product has a Nutrition Facts panel, this Policy does not apply to you.”

Amazon has relaxed the Certificate of Analysis (COA) requirements in a couple of ways.

Very likely in reaction to industry feedback, Amazon will now accept COAs that were issued within the past 12 months. Previously, the requirement was 9 months.

In addition, Amazon added a category of acceptable COAs:

A finished product Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with current good manufacturing practices (cGMP) per 21 CFR 111 and 117. A valid GMP certificate of the manufacturing facility must also be submitted. Amazon accepts GMP certificates from the following third-party programs: NSF (NSF/ANSI 173 Section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

This opens the door for COAs from in-house labs that may not be ISO/IEC 17025 accredited, but meet the above requirements. This may make it easier for brands and manufacturers to get COAs that meet Amazon’s requirements, as there are many in-house labs that are not ISO/IEC 17025 accredited.

Amazon has eliminated the Letter of Guarantee Requirement.

One of the requirements that existed in the earlier Policy was that manufacturers had to provide a letter of guarantee stating, among other things, that the products complied with various regulations, including the Good Manufacturing Practices (21 CFR Part 111) and 402(f) of the FD&C Act. The new version of the Policy does not require a Letter of Guarantee at all.

For the most part, these changes will likely be welcomed by brands that may have been unclear about the applicability of the Policy or had issues meeting the COA requirements. We are unsure of Amazon’s reasons for dropping the Letter of Guarantee requirement, but this could a boon for unauthorized sellers, who would have found it nearly impossible to obtain such a letter from a brand.

The Policy has changed significantly over the last few months, and we will continue to keep an eye on it for further changes as the May implementation date draws near. For additional information on what this new Policy may mean for your brands, please contact Adam Sherman at acsherman@vorys.com